NCT03810209

Brief Summary

To decrease post-operative pain in patients undergoing modified radical mastectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

January 16, 2019

Last Update Submit

April 9, 2024

Conditions

Serratus Anterior Plain Block

Outcome Measures

Primary Outcomes (1)

  • The duration of analgesia measured by the time of first analgesic request

    magnesium group showed delayed first analgesic request

    post operative 24 hours

Study Arms (2)

magnesium sulphate group

ACTIVE COMPARATOR

The investigator injected 28.5 mL of bupivacaine 0.5% and 1.5 ml MgSo4 (150 mg), a total volume of 30 ml, it was confirmed visually by the ultrasound.

Drug: Magnesium Sulphate

control group

PLACEBO COMPARATOR

The investigator injected 28.5 mL of Bupivacaine 0.5% and 1.5 mL of normal saline, a total volume of 30 ml, it was confirmed visually by the ultrasound.

Drug: Normal saline

Interventions

Magnesium SulphateDRUG

adding magnesium sulphate to local anaesthetic in SAP Block

Also known as: MgSO4
magnesium sulphate group
Normal salineDRUG

adding normal saline to local anaesthetic in SAP block

Also known as: NaCl
control group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales with breast cancer for modified radical mastectomy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, female patients, ASA physical status I, II, and III aged older than 18 years scheduled for modified radical mastectomy surgery under general anesthesia.

You may not qualify if:

  • Any known allergies to the study drugs. Anatomical abnormalities or infections in the serratus region. Bleeding disorders e.g. thrombocytopenia, high INR, high PT in chronic liver or impaired kidney). Patients on chronic pain medications or regularly receiving analgesics. Pregnant or breast feeding patients. Body Mass Index (BMI) more than 35.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Magnesium SulfateSaline Solution

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • abdelrhman alshawadfy

    suez canal univesity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 18, 2019

Study Start

August 15, 2017

Primary Completion

December 11, 2018

Study Completion

January 9, 2019

Last Updated

April 10, 2024

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)